Disorders involving abnormal functioning of the gastrointestinal tractafflict large segments the world's population. The most prevalent of the functional disorder in the absence of structural abnormalities is irritable bowel syndrome (IBS). The most common inflammatory gastrointestinal diseases are inflammatory bowel disease (IBD, which includes Crohn's disease, ulcerative colitis and indeterminate colitis) and gastritis. These conditions profoundly affect the quality of life of sufferers, and incur significant economic costs (Engel & Neurath, 2010; Loftus et al., 2000; Longstreth et al., 2006; Madden & Hunter; Salonen et al., 2010). IBS is estimated to affect 5 million Americans. IBS is characterized by recurring symptoms of abdominal pain, bloating, and altered bowel function in the absence of structural abnormalities. IBD affects between 2 to 6 percent of Americans. IBD is characterized by frequent and progressive symptoms of abdominal pain, diarrhea, rectal bleeding, and weight loss. Gastritis is estimated to affect 4.5 million people in the United States. Gastritis involves a chronic inflammation of the stomach, leading to upper abdominal pain and nausea. Gastritis is also the main cause of acquired failure of the gastric acid barrier, which results in the development of duodenal and gastric ulcers and stomach cancer in patients with H. pylori infection.
There is now evidence that these complex disorders have something in common: an imbalance (dysbiosis) between protective and harmful gastrointestinal organisms, even when no specific pathogen can be identified (Blaser, 1998; Bullock et al., 2004; Collins et al., 2009; Corthesy et al., 2007; Lin, 2004; Ott et al., 2004; Pimental et al., 2011; Salonen, et al., 2010). The role of dysbiosis in these diseases provides the rationale for the use of agents such as antibiotics, which alter the microbial composition of the GI tract. However, the use of antibiotics has been linked to serious side effects, complications, and bacterial resistance (Engel & Neurath, 2010; Grundmann et al., 2010). Moreover, antimicrobial therapies provide inferior results compared with antimicrobial therapies for other common infectious diseases (Camilleri & Tack, 2010; Rimbara et al., 2011).
IBS is classified as a functional disorder because there is no sign of disease when the small intestine and colon are examined. IBS is characterized by recurring symptoms of abdominal pain, bloating, and altered bowel function in the absence of structural abnormalities (see Brandt et al., 2009; Chang & Talley, 2010; Grundman et al., 2010). According to the Rome II criteria, IBS sufferers can be grouped into three symptom subtypes based on the stool form, stool frequency and defecatory symptoms: diarrhea predominant (IBS-D), constipation predominant (IBS-C), and mixed subtype (IBS-M) with alternating episodes of both diarrhea and constipation. More recently, the Rome III criteria, which focus on the stool form over the defecation frequency, have been issued (Longstreth et al., 2006). The most important physiological aberrations in IBS include visceral hypersensitivity, abnormal gut motility and autonomous nervous system dysfunction, the interactions of which are suggested to make the bowel function susceptible to a number of exogenous and endogenous factors, such as the GI microbiota, diet and psychosocial factors.
The presence of low-level inflammation in the GI mucosa of IBS patients has also been observed. Several studies have examined the fecal flora of IBS patients and found a decrease in Escherichia coli, lactobacilli, and bifidobacteria and an increase in aerobic microorganisms in comparison with healthy volunteers (Jonkers & Stockbrugger, 2007; Madden & Hunter, 2002; Salonen et al., 2010).
Inflammatory bowel disease (IBD) is a chronic inflammatory condition that includes Crohn's disease and ulcerative colitis (Longstreth et al., 2006; Engel & Neurath, 2010; Loftus et al., 2000). The causes of IBD are not known, but a leading theory suggests that some agent, perhaps a virus or bacterium, alters the body's immune response, triggering an inflammatory reaction in the intestinal wall. Crohn's disease most commonly affects the small intestine and/or the colon, whereas ulcerative colitis affects the large intestine, primarily the sigmoid/rectal region of the large bowel. The diagnosis of IBD is suggested by the symptoms of abdominal pain, rectal bleeding, and diarrhea. The ultimate diagnosis relies on a combination of history, endoscopic finding, histologic features, and negative stool studies for infectious agents (Silverberg et al., 2005). Cases that cannot be diagnosed as either ulcerative colitis or Crohn's disease are called indeterminate colitis. No specific microorganism has yet been described as a possible causal factor in IBD. However, a change in the bacterial composition of both the fecal and mucosal microbiota has been observed (Ott et al., 2004).
Gastritis involves a chronic inflammation of the stomach and duodenum that is typically associated with H. pylori infection. Upper abdominal pain and nausea are the most common symptoms; other symptoms are indigestion, abdominal bloating, nausea, and vomiting. Gastritis may be associated with pernicious anemia. The main acute causes of gastritis are excessive alcohol consumption or prolonged use of nonsteroidal anti-inflammatory drugs (also known as NSAIDs) such as aspirin or ibuprofen. Gastritis may develop after major surgery, traumatic injury, burns, severe infections, weight loss surgery involving the banding or reconstruction of the digestive tract, chronic bile reflux, stress, and certain autoimmune disorders. Gastroscopy, a blood test, urea
breath test, and/or stool test may be used to diagnose gastritis (Sepulveda & Patil, 2010).
The standard treatment for gastritis has been a one week “triple therapy” consisting of proton pump inhibitors and the antibiotics clarithromycin and amoxicillin, but the emergence of drug resistance has compromised the use of this regimen (Camilleri & Tack, 2010; Rimbara et al., 2011). The antibiotics ciprofloxacin and metronidazole have been used to treat gastritis, but the side effects of these antibiotics limits their use (Engel & Neurath, 2010; Grundman et al., 2010). A newer antibiotic, rifaximin, may be more effective than previous drugs (Pimental et al., 2010), but it is currently approved only for the treatment of traveler's diarrhea. IBD is usually treated with immunosuppressive agents. Frequently surgery is required. Therapy of IBS is directly at relieving symptoms and is often unsuccessful.
Because of studies suggesting that dysbiosis is important in the etiology of these disorders, there has been interest in identifying probiotic compositions that are capable of ameliorating the symptoms of IBS, IBD, and gastritis and improving the response to conventional treatments.
Additionally, it is well known that probiotics are described as “live microorganisms, which, when administered in adequate amounts, confer a health benefit on the host” (reports of the United Nations Food and Agricultural Organization and the World Health Organization, Alternative Medicine 2001). Probiotics are widely applied as nutritional supplements in animals and humans. For example, yeast is used as a nutrient supplement for livestock, and yogurt with lactic acid bacteria Lactobacillus and/or Bifidobacterium is commonly used to prevent and treat diarrhea-related gastrointestinal (GI) infectious diseases. Multiple unique properties of probiotics such as anti-infectious properties, immune modulatory effects, enhanced barrier functions, metabolic effects and alternations of intestinal mobility or function make probiotics an effective type alternative medicine for animals and humans.
Although probiotic products such as short-chain fatty acids (SCFA), cell wall peptidoglycan and short chain DNA fragments containing CpG sequences can have beneficial probiotics effects, the administration of live microorganisms to animals and humans remains the core application and focus of research studies of probiotics. In order to have the maximum effects of probiotics on animals and humans, one has to administrate live bacteria to reach gastrointestinal tracts for multiplication. Lactobacillus spp and Bifidobacterium spp are two most commonly probiotic genera described in scientific literature and in commercial products. Both Lactobacillus spp and Bifidobacterium spp are facultative or strict anaerobic bacteria. Most species (or strains) of Lactobacillus and Bifidobacterium are sensitive to the exposure of oxygen and high temperature. It is difficult to maintain the viability of Lactobacillus and Bifidobacterium at room temperature under consistent open and closure operations. Therefore, variable results are often described, especially for commercially available products that are required to have long term storage and shipping in various temperature.
In sum, there is a high frequency of incomplete or absent response of IBS, IBD and gastritis to current medical therapies. Thus there has gone unmet a need for improved methods, compositions, etc. that can ameliorate one or more symptoms associated with these diseases. Effective dietary and/or pharmaceutical interventions for these conditions could have a major public health impact. The present systems and methods, etc., provide these and/or other advantages.